Friday, 26 August 2016

Here's why leading doctors think the stomach-draining AspireAssist could actually help people.

Unless you’ve been avoiding cable news and Twitter lately (in which case we're jealous), you’ve probably heard about AspireAssist, the controversial new obesity treatment that was approved by the Food and Drug Administration last week.

Basically, it’s a tube that’s surgically inserted into a person’s stomach, and allows them to drain some of the food they’ve just eaten through a port valve and into a toilet. Approved for folks with a BMI between 35 and 55 (a BMI over 30 is classified as obese), the AspireAssist can prevent the body from absorbing nearly a third of a meal’s calories. (Here’s a video that shows how it works.)

Now, before we go any further, let’s just admit that our knee-jerk reaction was that this device sounds totally bonkers. We weren’t alone, either. The media dubbed it a "bulimia machine." Stephen Colbert explained it as "machine-assisted abdominal vomiting."

But is this opinion fair? Probably not.

“It’s not society’s job to judge [the AspireAssist] based on whether they think it’s morally okay or not,” says Yoni Freedhoff, MD, author of The Diet Fix and the director of the Bariatric Medical Institute in Ottawa, Canada. (For the record, he’s unaffiliated with the device.) “Our opinions should be based on evidence and results.”

And, he says, the data behind the AspireAssist is actually pretty good. A year-long trialfollowed 111 people who used the AspireAssist and compared them to 60 people who didn’t have the device. Both groups received dietary and lifestyle advice along the way. After 52 weeks, those who were using the AspireAssist lost 12.1% of their body weight, while the other group lost only 3.6%.

As for the criticism that the device mimics bulimia, it’s not approved for people with that very serious eating disorder. It’s not approved for anyone with binge eating disorder or nighttime eating disorder either.

There has also been concern that the device will encourage gluttony, or that people who opt for the AspireAssist will eat whatever they want, with a 30% discount on calories. (It almost sounds unfair, right?)

Only, that’s not what happened in the study, says Louis Aronne, MD, director of the Comprehensive Weight Control Center at Weill Cornell Medicine and New York-Presbyterian, and a researcher who was involved in the clinical trials of the device. “People didn’t keep eating,” he says. “They felt full.”

“People assume that [obesity] is under a person’s control,” says Dr. Arrone. “They think, ‘[That person] should stop eating as much.” But in fact, it’s more complicated than willpower alone.

When we eat, our brains produce hormones that eventually tell us we’re full, he says. But as time goes on and we gain weight, that “you’re full” signal may become blunted. He suspects that may explain why the AspireAssist can help people: They get the food they need to stay full, minus about one-third of the calories.

If it still seems like a quick-fix solution, keep in mind that the device needs to be surgically implanted, and you have to spend about 5 to 10 minutes after every meal draining your stomach. “[The AspireAssist] doesn’t sound like the easy way out,” says Dr. Freedhoff. “It sounds incredibly involved.”

Dr. Freedhoff said he was personally shocked by how many people have reached out to him and expressed negative reactions to the device. “I’ve never seen something more raked over the coals,” he says.

It might be because we tend to think people who can’t lose weight are “lazy, slothful, and gluttonous,” he says. Never mind the fact that obesity is a complicated mix of genetics and our environment—or that weight loss is pretty freaking hard for plenty of people.

Regardless of how people feel about this particular device, it’s time for all that to change, he says.

A weight-loss device approved by the FDA last week has some doctors up in arms, with one even attempting to put together 4,000 physicians to sue the agency. That’s because they say the device, which lets patients pump some of the food they've just eaten directly from their stomachs into the toilet, isn’t safe and may lead to eating disorders.

"This is the first time that I look at a device that was approved by the FDA and I am absolutely, utterly, and totally appalled that it was approved," says Joseph Gutman, an endocrinologist and diabetologist in Pembroke Pines, Florida, who has treated patients with obesity for over 30 years. Gutman says he’s put together a group of 750 physicians who want to sue the FDA to take the device off the market; his ultimate goal is to get 4,000 doctors to join him. "It is the most pathetic exhibition of ignorance on the part of our agency, the FDA. It is nothing but a bad trick. It’s like a bad joke."

The device, called AspireAssist, was approved by the FDA based on a one-year study of 111 people. The approval is for people with a body mass index (BMI) of 35 to 55 who have failed to lose weight with non-surgical therapies. (BMI is a measure of body fat based on height and weight; for a person who’s 5 feet 9 inches, the 35 to 55 BMI range translates to about 236 to 365 pounds.) AspireAssist also shouldn’t be used on patients who have eating disorders, the FDA says.

A person with AspireAssist has a tube surgically implanted through the abdomen into the stomach; it enters using a "port valve," an opening just above the belly button that patients can open or close to drain the food. After a meal, the patient waits 20 to 30 minutes before connecting the pump to the valve; the food is drained and dumped into the toilet. The process takes about 10 minutes and the device can remove up to 30 percent of the calories consumed with a meal, according to Kathy Crothall, president and CEO of Aspire Bariatrics, which makes the device and is based in King of Prussia, Pennsylvania.

There are some obvious side-effects: the port valve can cause infections and the tube can leak. But some experts fear that the device itself might trigger eating disorders. That’s because the device, in some sense, mimics bulimia — a disorder where people binge eat and then throw up. "Instead of throwing up through the throat, you throw up through the tube," Gutman says. "This is mechanized bulimia. It’s a device that makes bulimia okay."

The company says that binge eating on the device isn’t possible; patients must chew their food too thoroughly to binge. If they don’t chew long enough, the food gets stuck in the tube, which is no bigger than a straw, says Shelby Sullivan, who led one of the trials of the device on 17 people at Washington University in St. Louis with funding from Aspire Bariatrics. Lotta Frisk, 52, who lost 148 pounds over four years thanks to the device, says she chews every bite from 55 to 75 times. "I can’t put in food and throw it out," she says. "I need to chew."

Because patients have to chew longer, they eat more slowly and often feel full faster, Sullivan says. And that may make patients eat less. "At some point they just get tired of chewing," she says. "So they are feeling that full sensation with less food because they’re eating slower and they’re also literally just getting sick and tired of chewing."

Eric Wilcoxon, 44, who’s had the device since 2013, agrees. Because of all the chewing, Wilcoxon says he has smaller meals and also eats more fruits, steamed vegetables, and grilled chicken, which are all easier to chew and aspirate with the device. "You have to chew your food beyond comprehension," he says. "I mean, you just don’t grasp how much you have to chew your food."

Wilcoxon, from Poplar Bluff, Missouri, lost 128 pounds with AspireAssist. He was 389 pounds when he decided to get the device in the clinical trial at Washington University, after ruling out bariatric surgery for fear of the complications. AspireAssist was more appealing, because it’s reversible. He also saw one of his best friends lose a lot of weight with a gastric band, a silicone device wrapped around the stomach that restricts the amount of food a person can eat — only to gain it back once the band was removed.

He plans to keep the device indefinitely, he says. That’s because it still lets him enjoy his favorite foods. "If we want to go out tonight after my boy’s ball game and if I want to have a great, big ribeye, I can," he says. "I don’t have to aspirate every meal."

Chewing isn’t the only behavioral change, Sullivan says. She argues that people who use the device make healthier choices for meals because they actually see what comes out of their stomachs and think twice about it. "Healthy food doesn’t look that bad. It looks about the same as it came in, it’s just chewed up," she says. "Things like hamburgers and french fries, now that does not look good."

The FDA approved the device based on a small clinical trial that only ran a year. That makes some experts nervous about the long-term effects for patients like Wilcoxon. "There’s no scientific basis in the long term as to what this does," Gutman says. "The studies are incomplete." It’s also hard to know how the patients will react once the device is removed. Will they regain all their weight back, as it’s often the case with temporary obesity treatments? "If the Aspire device is meant to be there for a year or two, the moment you remove it, patients will have a 98 percent chance to regain all the weight back," says Raul Rosenthal, president of the American Society for Metabolic and Bariatric Surgery. That’s because most people regain weight after diets, often because they go back to unhealthy behavior.

Others worry that the device will give patients the impression that they can eat as much as they want, because they can just pump the food out afterwards. Instead, curing obesity means changing eating habits, teaching patients to eat less and eat healthier foods, combined with exercise. "I find it difficult to see how this won’t be seen as an easy way out, to the sense that people can eat more and not absorb the calories," says Konstantinos Spaniolas, a bariatric surgeon at the Brody School of Medicine at East Carolina University.